Integrated Cardiac Safety Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance

The serious nature of cardiovascular adverse drug reactions occurring in patients makes assessment of a drug's cardiac safety profile a high priority during both development and post-approval monitoring. Integrated Cardiac Safety provides necessary guidance and methodology for professionals assessing cardiac safety of drugs throughout all stages of the drug's life, from discovery and development through postmarketing research. This self-contained, reader-friendly text is valuable to professionals in the pharmaceutical, biotechnology, and CRO industries, pharmacologists, toxicologists, government officials, and students.

J. Rick Turner, PhD, PGCE, MICR, is Chairman, Department of Clinical Research at Campbell University School of Pharmacy. Dr. Turner has extensive teaching, research, and pharmaceutical credentials and more than a dozen awards and honors, including a Commit to Product Development Award from GlaxoSmithKline. He is the author of seven books and more than 100 journal articles and published abstracts. Todd A. Durham, MS, is Senior Director of Biostatistics and Data Management at Inspire Pharmaceuticals. Prior to joining Inspire, Mr. Durham served as Associate Director of Biostatistics at Quintiles, Inc. Mr. Durham has made significant statistical contributions to six NDA submissions and has been involved with five presentations to FDA advisory committees.

Foreword.

Preface.

Acknowledgments.

Abbreviations.

PartA I: INTRODUCTION.

1. The Importance of Cardiac Safety Assessments.

2. The Biological Basis of Adverse Drug Reactions.

PartA II: CARDIAC FUNCTION AND PATHOLOGY.

3. Cardiac Structure and Function.

4. Cardiac Pathophysiology and Disease.

SECTION III: DRUG DISCOVERY AND NONCLINICAL DEVELOPMENT.

5. Drug Discovery and Drug Design.

6. Nonclinical Development.

SECTION IV: PREAPPROVAL CLINICAL DEVELOPMENT.

7. The Thorough QT/QTc Trial.

8. General Safety Assessments.

SECTION V: POSTMARKETING ASSESSMENT METHODOLOGIES.

9. Therapeutic Use Trials and Meta-analyses.

10. Assessment Methodologies in Nonexperimental Postmarketing Surveillance.

11. Postmarketing Proarrythmic Cardiac Safety Assessments.

12. Generalized Cardiac Safety.

SECTION VI: BEHAVIORAL DRUG SAFETY.

13. Medication Errors, Adherence, and Concordance.

SECTION VII: INTEGRATIVE DISCUSSION.

14. Future Directions in Drug Safety.

References.

Index.